Exploring gut immunity's role in neurologic diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the functional profiles of immune cells in the gastrointestinal tract and their contribution to autoimmune and neurologic diseases such as Multiple Sclerosis and Parkinson's Disease. Participants undergoing colonoscopy will provide tissue biopsies from the gastrointestinal mucosa, allowing researchers to analyze immune cell interactions in detail using modern single-cell technologies. The study seeks to uncover the relationship between gut immunity and neurologic disease pathogenesis, potentially shifting current paradigms in understanding these conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 and up

ONE of the following:

* Recommended to under a screening colonoscopy (+/- upper endoscopy) as part of standard of care. This includes healthy individuals as well as those with neurologic and/or autoimmune diseases. OR
* Willing to undergo research colonoscopy (+/- upper endoscopy) for research

Exclusion Criteria:

* Currently pregnant. Women of childbearing potential would perform a point of care urine pregnancy test prior to colonoscopy/endoscopy.
* Known or suspected, chronic inflammatory gastrointestinal disease (e.g. inflammatory bowel disease)
* Known, acute or chronic infections
* Systemic antibiotic (PO or IV) use within 3 months of colonoscopy
* Systemic corticosteroid use (equivalent of prednisone 10 mg per day or higher for \>5 days) within 2 weeks of colonoscopy
* Malignancy, diagnosed or treated within the last 5 years
* Probiotic use within 2 weeks of procedure
* History of major GI surgery (e.g. colon resection, gastric bypass)
* Bleeding disorder, or on anticoagulant medication
* Other medical condition that, in the judgement of the investigator, would lead to higher-than-expected risks of biopsy
* Allergy to MAC anesthesia or other drugs used pursuant to standard of care for biospecimen collection

Where it's running

• Yale MS Clinic
  North Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Erin Longbrake — Yale University
• Study coordinator: Cynthia Marques
• Email: cynthia.marques@yale.edu
• Phone: 2032876100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.